Lifestyle Changes for Breast Cancer Risk Reduction

Overseen By Karen M. Basen-Engquist

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Invasive cancer, Renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Lifestyle Intervention, Intensive Lifestyle Intervention, Behavioral Therapy, Dietary Counseling, Physical Activity Intervention for breast cancer risk reduction?

Research shows that lifestyle changes, including a healthy diet and regular physical activity, can lower the risk of developing breast cancer and improve outcomes for those already diagnosed. These interventions can also help reduce the risk of cancer recurrence and improve overall health by managing weight and reducing the risk of other diseases like diabetes and heart disease. ^{1 2 3 4 5}

Is lifestyle intervention safe for humans?

Lifestyle interventions, which include diet and exercise changes, have been shown to be safe and beneficial for breast cancer patients, improving their overall health and well-being during and after treatment. ^{1 2 3 6 7}

How is the Lifestyle Intervention treatment for breast cancer risk reduction different from other treatments?

The Lifestyle Intervention treatment is unique because it focuses on making changes to daily habits, such as maintaining a healthy weight, eating a plant-based diet, exercising regularly, and avoiding alcohol, rather than using medication or surgery. This approach aims to prevent breast cancer by addressing lifestyle factors that can reduce risk, which is different from traditional treatments that typically focus on treating the disease after it has developed. ^{2 3 8 9 10}

What is the purpose of this trial?

This trial studies how well a lifestyle intervention works in reducing breast cancer risk through changing body composition and decreasing inflammation in normal weight women. This trial may help researchers learn more about diet and exercise programs designed to decrease body fat in postmenopausal women who are of normal weight but have an elevated risk of breast cancer because of excess body fat.

Research Team

Karen M. Basen-Engquist

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for postmenopausal women who are of normal weight with a BMI between 18.5 and <25, have excess body fat, no history of invasive cancer except non-melanoma skin cancer, no major surgery within the last 3 months, can exercise safely, and work at MD Anderson Cancer Center but not directly under the study's principal investigator.

Inclusion Criteria

No contraindications to exercise (either no positive responses on the Physical Activity Readiness Questionnaire, or clearance from a health care provider certifying that the participant is healthy enough to exercise)

Has internet access on a computer or mobile device

I have not had major surgery in the last 3 months.

Exclusion Criteria

You are currently doing strength exercises that work all major muscle groups two or more times per week.

MD Anderson employees that report to the principal investigator of this study

Participants that cannot engage in the exercise program for more than three weeks during the study period

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lifestyle Intervention

Participants complete lifestyle intervention consisting of high-resistance circuit training, aerobic training, and diet recommendations for 16 weeks

16 weeks

Weekly sessions with health coach or dietitian

Wait-list

Participants are placed on a wait-list before starting the lifestyle intervention

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

• Lifestyle Intervention

Trial Overview The trial tests if lifestyle changes like diet control and physical activities (resistance training and aerobic exercises) can reduce breast cancer risk by decreasing body fat and inflammation in normal-weight women with high breast cancer risk due to excess body fat.

Participant Groups

Group I: Group I (lifestyle intervention) Experimental Treatment 5 Interventions

Participants complete lifestyle intervention consisting of 1-3 sets of high-resistance circuit training sessions per week, up to 150 minutes of aerobic training per week, and diet recommendations from a health coach or registered dietitian twice per week for 16 weeks.

Group II: Group II (wait-list, lifestyle intervention) Active Control 5 Interventions

Participants are placed on a wait-list and then complete lifestyle intervention after 4 months.

Lifestyle Intervention is already approved in United States, European Union for the following indications:

Approved in United States as Lifestyle Intervention for:

• Obesity
• Weight Loss
• Type 2 Diabetes Prevention

Approved in European Union as Lifestyle Intervention for:

• Obesity
• Overweight
• Weight-Related Diseases

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Foundation for Women's Cancers

Collaborator

Trials

1

Recruited

50+

Findings from Research

Excess body fat and inactivity are linked to a higher risk of developing breast cancer and poorer outcomes for those diagnosed with early-stage breast cancer, highlighting the importance of lifestyle factors in cancer risk.

Ongoing clinical trials are exploring how weight management and physical activity after a breast cancer diagnosis can potentially reduce the risk of recurrence, while also providing additional health benefits like improved metabolism and reduced risk of other diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Management and Physical Activity for Breast Cancer Prevention and Control. Ligibel, JA., Basen-Engquist, K., Bea, JW.[2019]

A predominantly plant-based diet, along with regular physical activity and maintaining a healthy weight, plays a crucial role in preventing breast cancer and supporting treatment.

The article emphasizes the importance of personalized lifestyle recommendations for patients, based on evidence from the World Cancer Research Fund/American Institute for Cancer Research, to enhance cancer prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast Cancer: A Lifestyle Medicine Approach. Orman, A., Johnson, DL., Comander, A., et al.[2021]

Lifestyle interventions that include nutrition education, physical activity, and stress management can significantly improve the overall health of breast cancer patients.

Implementing a structured lifestyle intervention program is essential for enhancing the well-being of individuals undergoing treatment for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle Intervention for Breast Cancer Women. Hwang, ES., Nho, JH.[2020]

Breast cancer is the most diagnosed cancer in women, with 2.3 million new cases in 2020, and lifestyle interventions like a healthy diet and daily exercise can significantly reduce the risk of developing invasive breast cancer and help mitigate treatment side effects.

Despite the clear benefits of lifestyle changes, their implementation among at-risk individuals and survivors remains limited, highlighting the need for better education and outreach from oncology providers to promote these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Healthy Diet and Physical Activity With Breast Cancer: Lifestyle Interventions and Oncology Education. Jia, T., Liu, Y., Fan, Y., et al.[2022]

The SUCCESS C study is the first European trial to investigate how an intensive lifestyle intervention program affects disease-free survival in 3,547 women with early-stage, Her2/neu-negative breast cancer, highlighting the potential impact of lifestyle changes on cancer outcomes.

The trial will compare two chemotherapy regimens and assess the effectiveness of a telephone-based lifestyle intervention for women with a body mass index of 24-40 kg/m², aiming to determine if weight loss can improve survival rates and reduce recurrence risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The German SUCCESS C Study - The First European Lifestyle Study on Breast Cancer. Rack, B., Andergassen, U., Neugebauer, J., et al.[2022]

A pilot study involving 40 women undergoing chemotherapy for breast cancer showed that a weight control program combining a low-fat, high fruit-vegetable diet and moderate physical activity is feasible and well-received, with 75% of participants completing the 12-month study.

The intervention led to significant improvements in fruit and vegetable intake, physical activity, and breast cancer-specific well-being, while participants in the intervention group experienced a decrease in body fat compared to those receiving only written materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Diet and Exercise Intervention during Chemotherapy for Breast Cancer. Djuric, Z., Ellsworth, JS., Weldon, AL., et al.[2021]

The BWEL trial is a large randomized controlled study involving 3,181 women with stage II or III breast cancer, aiming to determine if a telephone-based weight-loss intervention can reduce cancer recurrence risk by promoting a weight loss of at least 10%.

The intervention includes 42 sessions over 2 years focusing on increased physical activity and caloric restriction, with the potential to significantly improve cancer outcomes and influence future care for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Breast Cancer Weight Loss trial (Alliance A011401): A description and evidence for the lifestyle intervention. Delahanty, LM., Wadden, TA., Goodwin, PJ., et al.[2023]

Maintaining a healthy lifestyle, including regular exercise, weight control, and a plant-based diet, can significantly reduce the risk of developing breast cancer, particularly in postmenopausal women.

Implementing targeted prevention programs for high-risk women and promoting healthy habits during childhood and adolescence could potentially prevent 25% to 30% of breast cancer cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can diet and lifestyle prevent breast cancer: what is the evidence? Harvie, M., Howell, A., Evans, DG.[2022]

Implementing lifestyle education based on the 2018 American Institute for Cancer Research recommendations is a cost-effective strategy for the primary prevention of breast cancer.

Key lifestyle changes include maintaining a healthy weight, adopting a low-fat, plant-based diet, engaging in regular physical activity, and avoiding alcohol, which should be integrated into routine patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle for breast cancer risk reduction. Mussallem, D.[2022]

Breast cancer (BC) has received significant public attention, but evidence-based preventive strategies are not as well emphasized, despite advancements in treatment for various BC subtypes.

The review aims to highlight key lifestyle factors linked to BC and provide practical prevention strategies that can be implemented in clinical practice, addressing the gap in long-term prevention studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of lifestyle factors on breast cancer risk. Dieterich, M., Stubert, J., Reimer, T., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Weight Management and Physical Activity for Breast Cancer Prevention and Control. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Breast Cancer: A Lifestyle Medicine Approach. [2021]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Lifestyle Intervention for Breast Cancer Women. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Association of Healthy Diet and Physical Activity With Breast Cancer: Lifestyle Interventions and Oncology Education. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The German SUCCESS C Study - The First European Lifestyle Study on Breast Cancer. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A Diet and Exercise Intervention during Chemotherapy for Breast Cancer. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

The Breast Cancer Weight Loss trial (Alliance A011401): A description and evidence for the lifestyle intervention. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Can diet and lifestyle prevent breast cancer: what is the evidence? [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Lifestyle for breast cancer risk reduction. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Influence of lifestyle factors on breast cancer risk. [2020]